EP3771425A1 - Einführvorrichtung für einen biosensor und einführverfahren dafür - Google Patents

Einführvorrichtung für einen biosensor und einführverfahren dafür Download PDF

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Publication number
EP3771425A1
EP3771425A1 EP20189213.0A EP20189213A EP3771425A1 EP 3771425 A1 EP3771425 A1 EP 3771425A1 EP 20189213 A EP20189213 A EP 20189213A EP 3771425 A1 EP3771425 A1 EP 3771425A1
Authority
EP
European Patent Office
Prior art keywords
seat
retraction
main body
sensor assembly
automatic
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP20189213.0A
Other languages
English (en)
French (fr)
Inventor
Chun-Mu Huang
Chieh-Hsing Chen
Chen-Hao Lee
Kuan-Lin Chang
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Bionime Corp
Original Assignee
Bionime Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from TW109100958A external-priority patent/TWI723732B/zh
Application filed by Bionime Corp filed Critical Bionime Corp
Publication of EP3771425A1 publication Critical patent/EP3771425A1/de
Pending legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M5/2033—Spring-loaded one-shot injectors with or without automatic needle insertion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14503—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6848—Needles
    • A61B5/6849—Needles in combination with a needle set
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/322—Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston
    • A61M5/3234—Fully automatic needle retraction, i.e. in which triggering of the needle does not require a deliberate action by the user
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/04—Constructional details of apparatus
    • A61B2560/0443—Modular apparatus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/06—Accessories for medical measuring apparatus
    • A61B2560/063—Devices specially adapted for delivering implantable medical measuring apparatus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/683—Means for maintaining contact with the body
    • A61B5/6832—Means for maintaining contact with the body using adhesives
    • A61B5/6833—Adhesive patches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/206—With automatic needle insertion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3303—Using a biosensor

Definitions

  • the disclosure relates to an insertion device and an insertion method thereof, and more particularly to an insertion device for a biosensor and an insertion method thereof.
  • a conventional insertion device disclosed in U.S. Patent No. 10413183 is for inserting a biosensor into a host, and includes a plunger, and a piercing member to which the sensor assembly is mounted.
  • the piercing member is inserted into the host upon depression of the plunger, but is not separated from the host until the plunger is released. Accordingly, the conventional insertion device is operated via a two-action operation. When an operator fails to promptly release the plunger, the piercing member remains to be inserted into the host and may cause discomfort of the host.
  • an object of the disclosure is to provide an insertion device that can alleviate the drawback of the prior art.
  • the insertion device includes a cover body, an insertion module.
  • the cover body has an accommodating space.
  • the insertion module is disposed in the accommodating space, and includes a main body, a main cover, an insertion seat, a pre-compressed first elastic member, a retraction seat, a pre-compressed second elastic member, a base and a sensor assembly.
  • the main body is coupled to the main cover, and cooperates with the main cover to define a displacement space therebetween.
  • the insertion seat is removably positioned in the main cover, and is able to move in the displacement space between the main body and the main cover.
  • the pre-compressed first elastic member has two opposite ends that respectively abut against the insertion seat and the main cover.
  • the retraction seat is removably positioned relative to the insertion seat.
  • the pre-compressed second elastic member has two opposite ends that respectively abut against the insertion seat and the retraction seat.
  • the base is separably positioned relative to the main body.
  • the sensor assembly is to be separably mounted to the base.
  • the cover body After the automatic-insertion operation is done, the cover body is positioned relative to the main body without rebounding, and a limiting structure between the insertion seat and the retraction seat collapses upon the collapse of the limiting structure between the insertion seat and the main cover, so that the retraction seat is driven by a restoring force of the pre-compressed second elastic member to perform an automatic-retraction operation.
  • the restoring force of the pre-compressed first elastic member is configured not to act on the cover body during depression of the cover body.
  • Another object of the disclosure is to provide an insertion method that can alleviate the drawback of the prior art.
  • the insertion method includes: an insertion device including a displacement space that is cooperatively defined by a main cover and a main body; an insertion module disposed in the displacement space, the insertion module being movable in the displacement space by compressed first and second elastic members therein so as to perform an automatic-insertion operation and an automatic-retraction operation; an insertion limiting structure disposed between the insertion module and the main body for removably positioning the insertion module at a pre-insertion position; and a retraction limiting structure disposed between the insertion module and the main cover, the insertion module being able to move from a post-insertion position to the pre-insertion position when the retraction limiting structure is collapsed.
  • the insertion limiting structure When the insertion device is kept being depressed, the insertion limiting structure is collapsed, and the insertion module is biased by a restoring force of the first elastic member to move downwardly to perform the automatic-insertion operation.
  • the retraction limiting structure is collapsed immediately after the insertion module finishing the automatic-insertion operation, such that the insertion module is biased by a restoring force of the second elastic member to move upwardly to perform the automatic-retraction operation.
  • the insertion module positions a sensor assembly thereof onto a base during the automatic-insertion operation.
  • a time needed for performing the automatic-insertion operation and the automatic-retraction operation is no more than 100 milliseconds, no more than 8 milliseconds, no more than 4 milliseconds or no more than 2 milliseconds.
  • a first embodiment of the insertion device is for inserting a sensor into a host.
  • the insertion device may be in the form of a canister (e.g., a desiccant canister), but is not limited to such.
  • the insertion device includes an upper casing 10 and an insertion module 30.
  • the upper casing 10 has an accommodating space 14 (see Figure 4 ), and a pair of casing engaging structures 124 (see Figure 4 ).
  • the insertion module 30 is disposed in the accommodating space 14, and includes a main body assembly 300, an insertion seat 33, a first elastic member 34, a retraction seat 35, a second elastic member 37, a base 50 and a sensor assembly 70.
  • the main body assembly 300 includes an upper portion 302, and a lower portion 303 that cooperates with the upper portion 302 to define a displacement space 301 therebetween.
  • the lower portion 303 of the main body assembly 300 has a pair of body engaging structures 315 that abut against inner sides of the casing engaging structures 124 of the upper casing 10, and that are able to respectively engage the casing engaging structures 124 of the upper casing 10 when the upper casing 10 is depressed downwardly.
  • the insertion seat 33 is removably positioned in the upper portion 302 of the main body assembly 300, and is able to move in the displacement space 301 between the upper portion 302 and the lower portion 303 along an axial line (L).
  • the upper casing 10 has a pair of urging portions 123 (see Figure 4 ).
  • the lower portion 303 of the main body assembly 300 has a pair of stopping portions 317 (see Figure 4 ).
  • the insertion seat 33 has a pair of buckle portions 335 (see Figure 4 ) that respectively and separably abut against the stopping portions 317 of the lower portion 303 of the main body assembly 300 so as to position the insertion seat 33 relative to the main body assembly 300, and that are able to be respectively pushed by the urging portions 123 of the upper casing 10 to be respectively separated from the stopping portions 317 of the lower portion 303 of the main body assembly 300.
  • the buckle portions 335 of the insertion seat 33 respectively and separably abut the stopping portions 317 of the lower portion 303 of the main body assembly 300 so as to form an insertion limiting structure (A) (see Figure 4 ).
  • the insertion seat 33 further has at least one limiting groove 330 (see Figure 4 ).
  • the upper portion 302 of the main body assembly 300 has at least one limiting member 323 (see Figure 4 ) that removably engages with the limiting groove 330 of the insertion seat 33.
  • the insertion seat 33 further has at least one retraction positioning portion 334 that separably abuts against the limiting member 323 of the upper portion 302 of the main body assembly 300.
  • the first elastic member 34 has two opposite ends respectively abutting against the insertion seat 33 and the upper portion 302 of the main body assembly 300.
  • the first elastic member 34 may be configured as a pre-compressed spring.
  • the retraction seat 35 is mounted with an insertion needle 36, and is removably positioned relative to the insertion seat 33.
  • the retraction positioning portion 334 of the insertion seat 33 is removably limited by the limiting member 323 of the upper portion 302 of the main body assembly 300, so as to form a retraction limiting structure (B) (see Figure 4 ) that positions the retraction seat 35 relative to the insertion seat 33.
  • the second elastic member 37 has two opposite ends respectively abutting against the insertion seat 33 and the retraction seat 35.
  • the second elastic member 37 may be configured as a pre-compressed spring.
  • the base 50 is separably positioned relative to the lower portion 303 of the main body assembly 300, and includes a base seat 51, and an adhesive pad 52 that is fixedly connected to the base seat 51.
  • the base 50 may further include a release layer 55 (see Figures 31 and 33 ) that is separably adhered to the adhesive pad 52.
  • the insertion module 30 further includes an auxiliary insertion seat 38 that is separably mounted to the insertion needle 36.
  • the sensor assembly 70 is separably mounted to the auxiliary insertion seat 38.
  • the auxiliary insertion seat 38 has a base portion 381, three angularly spaced-apart wing portions 382 each extending radially outwardly from the base portion 381, and a plurality of coupling portions 383 (see Figure 3 ) that protrude from a bottom surface of the base portion 381.
  • Each of the wing portions 382 has a plurality of notches 384, such that the wing portion 382 is flexible in a radial direction of the auxiliary insertion seat 38.
  • the upper portion 302 and the lower portion 303 of the main body assembly 300 are interconnected, a top portion of the upper casing 10 and a top portion of the upper portion 302 of the main body assembly 300 are spaced apart from each other by a distance (D) (see Figure 3 ), the buckle portions 335 of the insertion seat 33 respectively abut against the stopping portions 317 of the lower portion 303 of the main body assembly 300 so as to position the insertion seat 33 at a pre-insertion position, the first elastic member 34 is pre-compressed between the insertion seat 33 and the upper portion 302 of the main body assembly 300 to generate a restoring force, the second elastic member 37 is pre-compressed between the retraction seat 35 and the insertion seat 33 to generate a restoring force, the retraction seat 35 is at a pre-insertion position, the coupling portions 383 of the auxiliary insertion seat 38 is fitted into the coupling portion 711 of the sensing seat 71 so that the sens
  • the insertion operation performed by the first embodiment is illustrated as follows: Referring to Figures 5 and 6 , the adhesive pad 52 is adhered to a skin surface of the host. Referring to Figures 7 and 8 , when the upper casing 10 is not depressed, the insertion limiting structure (A) that is formed between the buckle portions 335 of the insertion seat 33 and the stopping portions 317 of the lower portion 303 of the main body assembly 300 maintains the insertion seat 33 at the pre-insertion position.
  • the buckle portions 335 of the insertion seat 33 are respectively pushed by the urging portions 123 of the upper casing 10 to be deformed inwardly and to be respectively separated from the stopping portions 317 of the lower portion 303 of the main body assembly 300, so that the insertion limiting structure (A) is collapsed.
  • the body engaging structures 315 of the main body assembly 300 respectively engage the casing engaging structure 124 of the upper casing 10, so that the upper casing 10 is positioned relative to the main body assembly 300.
  • the restoring force of the first elastic member 34 is permitted to be released, and moves the insertion seat 33 to an insertion position to implement automatic-insertion, such that the sensor assembly 70 is moved by the insertion seat 33 to a post-insertion position, that a portion of the sensor 72 is inserted underneath the skin surface, and that the sensing seat 71 is positioned onto the mounting portion 500 of the base 50.
  • the limiting member 323 of the upper portion 302 of the main body assembly 300 is separated from the limiting groove 330 and the retraction positioning portion 334 of the insertion seat 33, so that the retraction positioning portion 334 is permitted to be deformed outwardly to collapse the retraction limiting structure (B).
  • the restoring force of the second elastic member 37 is permitted to be released, and drives the retraction seat 35 to move past the retraction positioning portion 334 of the insertion seat 33 away from the skin surface, such that the insertion needle 36 is separated from the auxiliary insertion seat 38 and is retracted into the insertion seat 33 to hide a needle 362 thereof and to implement automatic-retraction (see Figures 11 and 12 ).
  • the coupling portions 383 of the auxiliary insertion seat 38 is maintained to be fitted into the coupling portion 711 of the sensing seat 71 so that the auxiliary insertion seat 38 is connected to the sensing seat 71 of the sensor assembly 70.
  • the upper casing 10 and the insertion module 30 are separated from the base 50 and the skin surface of the host (the auxiliary insertion seat 38 is separated from the sensing seat 71 of the sensor assembly 70), so as to finish the insertion operation of the first embodiment of the insertion device including the automatic-insertion and automatic-retraction operations (see Figures 13 , 14 and 28 ).
  • the first embodiment of the insertion device is operated via a single-action operation.
  • the insertion seat 33 is driven by the compressed first elastic member 34 to move toward the skin surface so as to perform the automatic-insertion operation and to separate the limiting structures (i.e., the limiting groove 330 and the limiting member 323) between the insertion seat 33 and the upper portion 302 of the main body assembly 300.
  • the upper casing 10 is positioned relative to the main body assembly 300 without rebounding, and the limiting structures between the insertion seat 33 and the upper portion 302 are separated from each other, so that the retraction seat 35 is driven by the pre-compressed second elastic member 37 to perform the automatic-retraction operation.
  • a time needed for performing the automatic-insertion operation and the automatic-retraction operation is no more than 100 milliseconds.
  • the duration for which the insertion needle 36 is inserted into the host is no more than 100 milliseconds.
  • the duration may be no more than 50 milliseconds, no more than 8 milliseconds, no more than 6 milliseconds, no more than 4 milliseconds or no more than 2 milliseconds.
  • a modification of the first embodiment of the insertion device according to the disclosure is for inserting a sensor into a host.
  • the modification may also be in the form of a canister (e.g., a desiccant canister), but is not limited to such.
  • the modification of the insertion device includes an upper casing 10, a lower casing 20, an insertion module 30, a base 50 and a desiccant 60.
  • the upper casing 10 includes an outer shell 11, and a cover body 12 that is disposed in the outer shell 11.
  • the cover body 12 has at least one casing engaging structure 124 at a lower portion thereof.
  • the outer casing 11 has an annular protruding portion 115 and an upper positioning portion 116.
  • the lower casing 20 is separably and airtightly connected to the upper casing 10 so as to form an airtight space 200 (see Figure 4 ) therebetween.
  • the desiccant 60 is disposed in the airtight space 200.
  • the lower casing 20 has a top edge 233.
  • the top edge 233 of the lower casing 20 is provided with a lower positioning portion 227 that corresponds in position and shape to the upper positioning portion 116 of the upper casing 10.
  • the lower casing 20 further has at least one abutment portion 228 at an inner surrounding surface thereof that abuts against an outer side of the casing engaging structure 124 of the upper casing 10, and an annular groove 224 at the inner surrounding surface thereof that permits the annular protruding portion 115 of the upper casing 10 to engage therewith so as to interconnect the upper casing 10 and the lower casing 20.
  • the insertion device may further include a sealing ring 13 (see Figures 3 and 4 ) that is disposed between the annular protruding portion 115 of the upper casing 10 and the annular groove 224 of the lower casing 20 for enhancing air-tightness of the airtight space 200 defined between the upper casing 10 and the lower casing 20.
  • the insertion module 30 is disposed in the upper casing 10, and is able to be moved by the upper casing 10.
  • the insertion module 30 includes a main body assembly 300.
  • the main body assembly 300 includes a main body 31, and a main cover 32 that is connected to the main body 31 and that cooperates with the main body 31 to define a displacement space 301 therebetween.
  • the main body assembly 300 further has at least one body engaging structure 315 that abuts against an inner side of the casing engaging structure 124 of the upper casing 10. The body engaging structure 315 engages with the casing engaging structure 124 of the upper casing 10 when the upper casing 10 is depressed.
  • the body engaging structure 315 of the main body assembly 300 is disposed on the main body 31 of the main body assembly 300, and the body engaging structure 315 abuts against the inner side of the casing engaging structure 124 of the cover body 12 of the upper casing 10.
  • the abutment portion 228 of the lower casing 20 limits movement of the casing engaging structure 124 of the cover body 12 of the upper casing 10, such that the upper casing 10 cannot move downwardly so as to prevent unintentional insertion operation of the insertion device due to unintentionally applying force to the insertion device.
  • the insertion module 30 further includes an insertion seat 33 that is disposed in the displacement space 301, a first elastic member 34 that has two opposite ends respectively abutting against the insertion seat 33 and the main cover 32 for moving the insertion seat 33 in an insertion direction (F), a retraction seat 35 that is disposed in the insertion seat 33, an insertion needle 36 that is connected to the retraction seat 35, a second elastic member 37 that has two opposite ends respectively abutting against the insertion seat 33 and the retraction seat 35 for moving the retraction seat 35 in a retraction direction (R) opposite to the insertion direction (F), an auxiliary insertion seat 38 that is separably connected to the insertion needle 36, and a sensor assembly 70 that is separably connected to the auxiliary insertion seat 38.
  • the sensor assembly 70 includes a sensing seat 71, and a sensor 72 that is mounted to the sensing seat 71 and that is separably coupled to the insertion needle 36.
  • the first elastic member 34 and the second elastic 37 are configured as pre-compressed springs.
  • the cover body 12 of the upper casing 10 has a pair of urging portions 123 at an inner surrounding surface thereof.
  • the insertion seat 33 has a pair of buckle portions 335 (see Figure 4 ) that respectively and separably abut against two stopping portions 317 of the main body 31, and that are able to be respectively pushed by the urging portions 123 of the cover body 12 to be respectively separated from the stopping portions 317 of the main body 31.
  • the buckle portions 335 of the insertion seat 33 respectively and separably abut the stopping portions 317 of the main body 31 so as to form an insertion limiting structure (A) between the insertion seat 33 and the main body 31.
  • the insertion seat 33 further has at least one limiting groove 330.
  • the main cover 32 has at least one limiting member 323 that removably engages with the limiting groove 330 of the insertion seat 33.
  • the insertion seat 33 further has at least one retraction positioning portion 334 that separably abuts against the limiting member 323 of the main cover 32 and that limits movements of the retraction seat 35.
  • the retraction positioning portion 334 of the insertion seat 33 is limited by the limiting member 323 of the main cover 32, so as to form a retraction limiting structure (B) among the retraction seat 35, the insertion seat 33 and the main cover 32 of the main body assembly 300.
  • the sensor assembly 70 is to be separably mounted to the base 50, and includes a sensing seat 71, and a sensor 72 that is mounted to the sensing seat 71 and that is separably coupled to the insertion needle 36.
  • the sensing seat 71 has a coupling portion 711 (see Figure 3 ).
  • the base 50 is separably positioned relative to the main body 32 of the main body assembly 300, and permits the sensor assembly 70 to be mounted thereon after the sensor assembly 70 is separated from the auxiliary insertion seat 38.
  • the base 50 includes a base seat 51, an adhesive pad 52 that is fixedly connected to the base seat 51, and two base hook structures 54 (see Figure 3 ).
  • the base 50 may further include a release layer 55 (see Figures 31 and 33 ) that is separably adhered to the adhesive pad 52.
  • the base 50 further has a mounting portion 500 (see Figure 4 ) for the sensor assembly 70 to be separably mounted thereto.
  • the mounting portion 500 of the base 50 includes a recess 501 that permits the sensor assembly 70 to be press-fitted thereinto, or may include an adhesive layer 502 (e.g., double-sided tape) that is disposed in the recess 501 (see Figure 31 ), or at least one resilient hook 503 (see Figure 32 ) that is for engaging with the sensor assembly 70.
  • an adhesive layer 502 e.g., double-sided tape
  • at least one resilient hook 503 see Figure 32
  • the insertion device further includes a pair of fixing members 40.
  • the fixing members 40 are mounted to a slide groove 310 (see Figure 2 ) of the main body 31 of the main body assembly 300.
  • Each of the fixing members 40 has a push portion 41 that corresponds in position to a respective one of two stop portions 226 (see Figure 3 ) of the lower casing 20, a support portion 42 that is opposite to the push portion 41, a fixing hook structure 43 that is located between the push portion 41 and the support portion 42, and a cam portion 44 that is located between the push portion 41 and the support portion 42 and that has an inclined cam surface 441.
  • each of the fixing members 40 is limited by the respective one of the stop portions 226 of the lower casing 20, so that the fixing members 40 are positioned relative to the main body 31.
  • the sensing seat 71 of the sensor assembly 70 is supported by the support portions 42 of the fixing members 40 so as to be positioned relative to the main body 31.
  • the fixing hook structures 43 of the fixing members 40 respectively engage with the base hook structures 54 of the base 50.
  • the fixing members 40 interfere with the lower casing 20 and the cover body 12 of the upper casing 10, so that the upper casing 10 is prevented from moving downwardly by the fixing members 40 to further prevent unintentional insertion operation of the insertion device.
  • the base 50 is limited within the insertion device.
  • the upper casing 10 is permitted to be depressed, such that the cover body 12 moves downwardly to push and move the fixing member 40 laterally and outwardly so as to collapse the limiting structure among the fixing members 40, the sensor assembly 70 and the base 50.
  • the first elastic member 34 of the insertion module 30 is permitted to release the restoring force thereof to insert the insertion needle 36 and the sensor 72 of the sensor assembly 70 underneath the skin surface of the host, and the second elastic member 37 of the insertion module 30 is permitted to release the restoring force thereof to retract the insertion needle 36 to finish automatic-insertion and automatic-retraction operations.
  • a second embodiment, or a modification of the first embodiment of the insertion device according to the disclosure is for inserting a sensor into a host.
  • the outer shell 11 and the lower casing 20 (or the upper casing 20 and the lower casing 20) are airtightly coupled to each other, so that an inner space of the insertion device is airtight.
  • the desiccant 60 may be disposed at a suitable position anywhere in the inner space of the insertion device.
  • any one of the components of the insertion module 30 may be made of materials including desiccant through an injection molding technology (as shown in Figs. 22 and 23 ).
  • an inner surface of the outer shell 11 may be provided with a desiccant layer 62 (see Figures 25 and 26 ), or the sensor assembly 70 may have a desiccant 60 (not shown) so that the inner space of the insertion device is kept dry and that the sensor assembly 70 is prevented from being moistened.
  • the base 50 further includes a tearing element 23 that is fixedly mounted to a base plate 21 of the lower casing 20.
  • the tearing element 23 is connected to the release layer 55 (see Figures 31 and 33 ) that is separably adhered to the adhesive pad 52.
  • the tearing element 23 simultaneously separates the release layer 55 from the adhesive pad 52. Since the release layer 55 is not separated from the adhesive pad 52 until the insertion device is to perform the insertion operation, the adhesive pad 52 is prevented from being stained before the insertion operation.
  • the lower casing 20 is in the form of a cap. In other embodiments, the lower casing 20 may be in the form of an aluminum foil (not shown).
  • the outer shell 11 is sleeved onto the insertion module 30 after the components of the insertion module 30 are assembled.
  • the sensor assembly 70 has been mounted to the insertion module 30 via the auxiliary insertion seat 38 (see Figure 29 ), the lower casing 20 is subsequently coupled to the outer shell 11.
  • the sensor assembly 70 does not need to be manually adjusted during the insertion operation of the insertion device. It means that a user does not require additional manual operation of grasping the sensor assembly 70 onto the base 50 by the implanting module 30 (i.e., the insertion module 30).
  • all the components of the insertion device have been assembled in the factory, but can be disassembled and reassembled by medical personnel or a user (see Figure 30 ).
  • the user can easily manipulate the insertion device (e.g., by simply depressing the upper casing 10) to mount the base 50 onto the skin surface of the host by the adhesive pad 52 of the base 50 followed by coupling the sensor assembly 70 onto the base 50.
  • the insertion device e.g., by simply depressing the upper casing 10.
  • the separated lower casing 20 can be re-coupled to the upper casing 10.
  • the lower casing 20 can seal a bottom portion of the outer shell 11 by the engagement between the annular protruding portion 115 of the upper casing 10 and the annular groove 224 of the lower casing 20.
  • the engagement between the lower positioning portion 227 of the lower casing 20 and the upper positioning portion 116 of the upper casing 10 ensures that the lower casing 20 and the upper casing 10 are properly positioned to each other.
  • the inner space of the insertion device can serve as a waste storing space.
  • a used base 50 can be removed from the host and be placed in the inner space of the insertion device, such that the used insertion device can be disposed in compliance with standard of discard of medical waste.
  • the whole insertion operation of the insertion device according to the disclosure is shown in Figure 27 .
  • Figs. 28 shows that after the sensor 72 is implanted under the skin surface P of the living body, the sensor assembly 70 and the base 50 that are simultaneously disposed on the skin surface P of the living body, a transmitter 90 is installed on the base 50 in the form of an upper cover to process the physiological signals measured by the sensor 72 and allows the signals to be transmitted to the outside.
  • the inserter device of the present invention does not include a transmitter.
  • the separately arranged the transmitter 90 and the sensor assembly 70 are to ensure the electronic parts are not damaged by the sterilization process, so the production yield of the device can be improved.
  • a third embodiment of the insertion device (similar to the automatic needle insertion and automatic needle extraction of the first embodiment, but in this embodiment does not include the outer shell 11) can optionally have a bottom cover 20, or uses a sealed package to seal the insertion device.
  • the insertion device includes a cover body 12 and an insertion module 30.
  • the cover body 12 has an accommodating space 14, and a pair of casing engaging structures 124.
  • the insertion module 30 is disposed in the accommodating space 14, and includes a main body 31, an insertion seat 33, a first elastic member 34, a retraction seat 35, a second elastic member 37, a base 50 and a sensor assembly 70.
  • the main body 31 is associated with the cover body 12, and cooperates with the cover body 12 to define a displacement space 301 therebetween.
  • the main body 31 has a pair of body engaging structures 315 that are able to respectively engage the casing engaging structure 124 of the cover body 12.
  • the insertion seat 33 is removably positioned in the cover body 12, and is able to move in the displacement space 301 between the main body 31 and the cover body 12 along an axial line (L).
  • the cover body 12 has a pair of urging portions 123 on an inner surrounding surface thereof.
  • the main body 31 has a pair of stopping portions 317.
  • the insertion seat 33 has a pair of buckle portions 335 that respectively and separably abut against the stopping portions 317 of the main body 31 so as to position the insertion seat 33 relative to the main body 31, and that are able to be respectively pushed by the urging portions 123 of the cover body 12 to be respectively separated from the stopping portions 317 of the main body 31.
  • the buckle portions 335 of the insertion seat 33 respectively and separably abut the stopping portions 317 of the main body 31 so as to form an insertion limiting structure (A2) between the insertion seat 33 and the main body 31.
  • the insertion seat 33 further has at least one limiting groove 330.
  • the cover body 12 further has at least one limiting member 100 that removably engages with the limiting groove 330 of the insertion seat 33.
  • the insertion seat 33 further has at least one retraction positioning portion 334 that separably abuts against the limiting member 100 of the cover body 12.
  • the first elastic member 34 has two opposite ends respectively abutting against the insertion seat 33 and the cover body 12.
  • the first elastic member 34 may be configured as a pre-compressed spring.
  • the retraction seat 35 is mounted with an insertion needle 36, and is removably positioned relative to the insertion seat 33.
  • the retraction positioning portion 334 of the insertion seat 33 is removably limited by the limiting member 100 of the cover body 12, so as to form a retraction limiting structure (B2) that positions the retraction seat 35 relative to the insertion seat 33.
  • the second elastic member 37 has two opposite ends respectively abutting against the insertion seat 33 and the retraction seat 35.
  • the second elastic member 37 may be configured as a pre-compressed spring.
  • the base 50 is separably positioned relative to the main body 31, and includes a base seat 51, and an adhesive pad 52 that is fixedly connected to the base seat 51.
  • the sensor assembly 70 is to be separably mounted to the base 50, and includes a sensing seat 71, and a sensor 72 that is mounted to the sensing seat 71 and that is separably coupled to the insertion needle 36.
  • the base 50 further has a mounting portion 500 for the sensor assembly 70 to be separably mounted thereto, and the mounting methods are similar as those described in the previous embodiment.
  • the insertion module 30 further includes an auxiliary insertion seat 38 that is separably mounted to the insertion needle 36.
  • the sensor assembly 70 is separably mounted to the auxiliary insertion seat 38.
  • the auxiliary insertion seat 38 slidably engages with the main body assembly 300 to guide the insertion needle 36 to steadily insert the sensor 72 into the host without runout or inclination so as to alleviate pain of the host.
  • a fourth embodiment of the insertion device according to the disclosure (similar to the third embodiment but the insertion module includes independent main cover) includes a cover body 12 and an insertion module 30.
  • the cover body 12 has an accommodating space 14, and a pair of casing engaging structures 124.
  • the insertion module 30 is disposed in the accommodating space 14, and includes a main body 31, a main cover 32, an insertion seat 33, a first elastic member 34, a retraction seat 35, a second elastic member 37, a base 50 and a sensor assembly 70.
  • the main body 31 is connected to the main cover 32, and cooperates with the main cover 32 to define a displacement space 301 therebetween.
  • the main body 31 has a pair of body engaging structures 315 that are able to respectively engage the casing engaging structure 124 of the cover body 12. Atop portion of the cover body 12 and a top portion of the main cover 32 is spaced apart from each other by a distance (D).
  • the insertion seat 33 is removably positioned in the main cover 32, and is able to move in the displacement space 301 between the main body 31 and the main cover 32 along an axial line (L).
  • the cover body 12 has a pair of urging portions 123 on an inner surrounding surface thereof.
  • the main body 31 has a pair of stopping portions 317.
  • the insertion seat 33 has a pair of buckle portions 335 that respectively and separably abut against the stopping portions 317 of the main body 31 so as to position the insertion seat 33 relative to the main body 31, and that are able to be respectively pushed by the urging portions 123 of the cover body 12 to be respectively separated from the stopping portions 317 of the main body 31.
  • the buckle portions 335 of the insertion seat 33 respectively and separably abut the stopping portions 317 of the main body 31 so as to form an insertion limiting structure (A1) between the insertion seat 33 and the main body 31.
  • the insertion seat 33 further has at least one limiting groove 330.
  • the main cover 32 further has at least one limiting member 320 that removably engages with the limiting groove 330 of the insertion seat 33.
  • the insertion seat 33 further has at least one retraction positioning portion 334 that separably abuts against the limiting member 320 of the main cover 32.
  • the first elastic member 34 has two opposite ends respectively abutting against the insertion seat 33 and the main cover 32.
  • the first elastic member 34 may be configured as a pre-compressed spring.
  • the retraction seat 35 is mounted with an insertion needle 36, and is removably positioned relative to the insertion seat 33.
  • the retraction positioning portion 334 of the insertion seat 33 is removably limited by the limiting member 320 of the main cover 32, so as to form a retraction limiting structure (B1) that positions the retraction seat 35 relative to the insertion seat 33.
  • the second elastic member 37 has two opposite ends respectively abutting against the insertion seat 33 and the retraction seat 35.
  • the second elastic member 37 may be configured as a pre-compressed spring.
  • the base 50 is separably positioned relative to the main body 31, and includes a base seat 51, and an adhesive pad 52 that is fixedly connected to the base seat 51.
  • the sensor assembly 70 is to be separably mounted to the base 50, and includes a sensing seat 71, and a sensor 72 that is mounted to the sensing seat 71 and that is separably coupled to the insertion needle 36.
  • the base 50 further has a mounting portion 500 for the sensor assembly 70 to be separably mounted thereto, and the mounting methods are similar as those described in the previous embodiment.
  • the insertion module 30 further includes an auxiliary insertion seat 38 that is separably mounted to the insertion needle 36.
  • the sensor assembly 70 is separably mounted to the auxiliary insertion seat 38.
  • the auxiliary insertion seat 38 slidably engages with the main body assembly 300 to guide the insertion needle 36 to steadily insert the sensor 72 into the host without runout or inclination so as to alleviate pain of the host.
  • the insertion device according to the disclosure (the first to fourth embodiments and the modifications thereof) is operated in such a manner that the upper casing 10 or the cover body 12 is depressed so as to collapse the insertion limiting structure (A, A1, A2), and the first elastic member 34 therefore releases the restoring force to move the insertion seat 33 downwardly to perform the automatic-insertion operation.
  • the insertion needle 36 is driven to be inserted into the host by the first elastic member 34 rather than by manual depression of a user. Therefore, the insertion operation and the retraction operation can be smoothly performed by any user even if the user is not an adept operator.
  • the insertion operation performed by the third and fourth embodiments, according to the disclosure are operated via a single-action operation.
  • the insertion operation of the sensor 72 into the host is illustrated as follows: Referring to Figures 31 to 33 , when the adhesive pad 52 is adhered to a skin surface of the host and the cover body 12 is not depressed, the insertion limiting structure (A1, A2) that is formed between the buckle portions 335 of the insertion seat 33 and the stopping portions 317 of the main body 31 maintains the insertion seat 33 at a pre-insertion position.
  • the buckle portions 335 of the insertion seat 33 are respectively pushed by the urging portions 123 of the cover body 12 to be deformed inwardly and to be respectively separated from the stopping portions 317 of the main body 31, so that the insertion limiting structure (A1, A2) is collapsed.
  • the body engaging structures 315 of the main body 31 respectively engage the casing engaging structure 124 of the cover body 12, so that the cover body 12 is positioned relative to the main body 31.
  • the restoring force of the first elastic member 34 is permitted to be released, and moves the insertion seat 33 to an insertion position to implement automatic-insertion, such that the sensor assembly 70 is moved by the insertion seat 33 to a post-insertion position, that the sensor 72 is inserted underneath the skin surface, and that the sensing seat 71 is positioned onto the mounting portion 500 of the base 50.
  • the limiting member 320 of the main cover 32 or the limiting member 100 of the cover body 12 is separated from the limiting groove 330 and the retraction positioning portion 334 of the insertion seat 33, so that the retraction positioning portion 334 is permitted to be deformed outwardly to collapse the retraction limiting structure (B1, B2).
  • the restoring force of the second elastic member 37 is permitted to be released, and drives the retraction seat 35 to move past the retraction positioning portion 334 of the insertion seat 33 away from the skin surface, such that the insertion needle 36 is separated from the auxiliary insertion seat 38 and is retracted into the insertion seat 33 to hide a needle 362 thereof and to implement automatic-retraction.
  • the coupling portions 383 of the auxiliary insertion seat 38 is maintained to be fitted into the coupling portion 711 of the sensing seat 71 so that the auxiliary insertion seat 38 is connected to the sensing seat 71 of the sensor assembly 70.
  • the cover body 12 and the insertion module 30 are separated from the base 50 and the skin surface of the host, so as to finish the insertion operation of the third and fourth embodiments of the insertion device including the automatic-insertion and automatic-retraction operations.
  • the third and fourth embodiments of the insertion device may further include a lower casing (not shown) that is air-tightly and separably coupled to the cover body 12 so as to form an airtight space within the insertion device.
  • a desiccant may be provided in the inner space of the insertion device so as to prevent the sensor 72 of the sensor assembly 70 from being moistened.
  • a time needed for performing the automatic-insertion operation and the automatic-retraction operation is no more than 100 milliseconds, no more than 50 milliseconds, no more than 8 milliseconds, no more than 6 milliseconds, no more than 4 milliseconds or no more than 2 milliseconds;
  • the insertion module further includes an insertion seat 33 and a retraction seat 35.
  • the insertion limiting structure (A1, A2) is formed between the insertion seat 33 and the main body 31.
  • the retraction limiting structure (B1, B2) is formed among the insertion seat 33, the retraction seat 35 and the main cover 31 or among the insertion seat 33, the retraction seat 35 and the cover body 12.
  • the retraction seat 35 includes an insertion needle 36.
  • the insertion seat 33 includes a pushing portion (with reference to the reference numeral 337 in Figure 3 ). After the automatic-insertion operation performed by the insertion module 30, the insertion needle 36 is inserted through the base 50 to insert a sensor 72 underneath a skin surface of a host, and the pushing portion of the insertion seat 33 tightly abuts against the sensor assembly 70 (via an auxiliary insertion seat 38) so as to prevent the sensor assembly 70 from being separated from a mounting portion 500 of the base 50.
  • this disclosure further discloses a plurality of embodiments as defined by the claims, with each embodiment comprising the claim elements of the respective claim and the claim elements of any claim upon which the respective claim depends.

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EP20189213.0A 2019-08-02 2020-08-03 Einführvorrichtung für einen biosensor und einführverfahren dafür Pending EP3771425A1 (de)

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US201962882140P 2019-08-02 2019-08-02
TW109100958A TWI723732B (zh) 2019-08-02 2020-01-10 生物感測器之植入裝置及其植入方法

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US20040133164A1 (en) * 2002-11-05 2004-07-08 Funderburk Jeffery V. Sensor inserter device and methods of use
EP3251596A1 (de) * 2015-01-27 2017-12-06 Terumo Kabushiki Kaisha Sensoreinsatzvorrichtung und set aus sensoreinsatzvorrichtungen
WO2018222012A1 (ko) * 2017-06-02 2018-12-06 주식회사 아이센스 연속 혈당 측정기용 센서 어플리케이터 조립체
US10413183B2 (en) 2016-04-08 2019-09-17 Medtronic Minimed, Inc. Insertion device

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ES2690306T3 (es) * 2006-11-28 2018-11-20 F. Hoffmann-La Roche Ag Un dispositivo de inserción y método para insertar un elemento insertable de manera subcutánea en un cuerpo
CN115444410A (zh) * 2017-01-23 2022-12-09 雅培糖尿病护理公司 用于插入体内分析物传感器的施加器及组件
EP3632318B1 (de) * 2017-06-02 2024-07-03 I-sens, Inc. Sensorapplikatoranordnung für ein kontinuierliches blutzuckerüberwachungssystem

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Publication number Priority date Publication date Assignee Title
US20040133164A1 (en) * 2002-11-05 2004-07-08 Funderburk Jeffery V. Sensor inserter device and methods of use
EP3251596A1 (de) * 2015-01-27 2017-12-06 Terumo Kabushiki Kaisha Sensoreinsatzvorrichtung und set aus sensoreinsatzvorrichtungen
US10413183B2 (en) 2016-04-08 2019-09-17 Medtronic Minimed, Inc. Insertion device
WO2018222012A1 (ko) * 2017-06-02 2018-12-06 주식회사 아이센스 연속 혈당 측정기용 센서 어플리케이터 조립체

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